Trial Outcomes & Findings for Pharmacokinetics and Safety of Piperacillin-tazobactam in Neonates (NCT NCT00873327)

Results Overview

To study how Piperacillin is metabolized in the body by measuring the drug concentration in plasma samples collected at different time points during the study

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

32 participants

Primary outcome timeframe

2-3 days after infant receives 1st drug dosing

Results posted on

2018-10-03

Participant Flow

Infants recruited from intensive care nurseries.First subject was recruited/enrolled on 1/29/2010. Last subject was enrolled on 7/29/2010. A total of 32 subjects were enrolled at 4 participant sites.

Participant milestones

Participant milestones
Measure	GA of 32 Wks, PNA of 14 Days Open label -- 6 interval doses piperacillin-tazobactam : 6 doses intravenously at the following doses: Infants \<32 weeks gestation at birth \< 14 days postnatal age (PNA) 100 mg/kg Q8 ≥ 14 weeks PNA 100 mg/kg Q6 Infants ≥32 weeks gestation (GA) at birth \< 14 days PNA 100 mg/kg Q6 ≥ 14 days PNA 100 mg/kg Q6
Overall Study STARTED	32
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacokinetics and Safety of Piperacillin-tazobactam in Neonates

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GA of 32 Wks, PNA of 14 Days n=32 Participants Open label -- 6 interval doses piperacillin-tazobactam : 6 doses intravenously at the following doses: Infants \<32 weeks gestation at birth \< 14 days PNA 100 mg/kg Q8 ≥ 14 weeks PNA 100 mg/kg Q6 Infants ≥32 weeks gestation at birth \< 14 days PNA 100 mg/kg Q6 ≥ 14 days PNA 100 mg/kg Q6
Age, Categorical <=18 years	32 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	0.1 years STANDARD_DEVIATION 0 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2-3 days after infant receives 1st drug dosing

Population: All 32 subjects that were enrolled during the study.

To study how Piperacillin is metabolized in the body by measuring the drug concentration in plasma samples collected at different time points during the study

Outcome measures

Outcome measures
Measure	PK Analysis Cohort - Piperacillin Plasma Clearance n=32 Participants Open label -- 6 interval doses piperacillin-tazobactam : 6 doses intravenously at the following doses: Infants \<32 weeks gestation at birth \< 14 days PNA 100 mg/kg Q8 ≥ 14 weeks PNA 100 mg/kg Q6 Infants ≥32 weeks gestation at birth \< 14 days PNA 100 mg/kg Q6 ≥ 14 days PNA 100 mg/kg Q6
Piperacillin Pharmacokinetics (PK)	0.0799 L/hr/kg Interval 0.0677 to 0.093

Adverse Events

GA of 32 Wks, PNA of 14 Days

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Brian Smith, MD. MPH

Duke University Medical Center

Phone: 919-668-8951

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place